Social Anxiety DisorderSOFIE-5YFUNCT01145690
Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD)
An observational study of Social Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample is constituted by all 80 participants who received Internet-based CBT in 2005 within the context of a RCT in Sweden.
Who may be able to join
- Must have a primary diagnosis of social phobia
Who cannot join
- Substance abuse during the last 6 months
- Other dominating diagnosis (not phobic personality disorder)
- A history of bipolar disorder or psychosis
- Major depression according to DSM-IV and >20 on madrs-s
- Risk of suicide
- Start of medication or change of dosis during the last 2 months
- Other parallel psychological treatment
- Previous CBT (last 3 years) for social phobia
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Psykiatri Sydväst, Stockholm County Council
Stockholm, Stockholm County, 141 86
About this study
Official title: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder.
In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.
- Conditions
- Social Anxiety Disorder
- Keywords
- cognitive behaviour therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based CBT | All participants in this cohort received Internet-based CBT for social anxiety disorder in 2005. All participants were Swedish adults with a DSM-IV diagnosis of social anxiety disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS)
Measured: 5-year follow-up
Secondary outcomes (5)
Measures of social anxiety in interaction and performance situations - SIAS & SPS
Measured: 5-year follow-up
Measure of depressive symptoms - MADRS-S
Measured: 5-year follow-up
Measure of general anxiety - BAI
Measured: 5-year follow-up
Measure of quality of life - QOLI
Measured: 5-year follow-up
Measure of social anxiety disorder diagnosis - SPSQ
Measured: 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145690
- Sponsor's protocol ID
- SOFIE-5YFU
- Acronym
- SOFIE-5YFU
- Status last verified
- Jun 2010
- First submitted
- 15 Jun 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hedman E, Furmark T, Carlbring P, Ljotsson B, Ruck C, Lindefors N, Andersson G. A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. J Med Internet Res. 2011 Jun 15;13(2):e39. doi: 10.2196/jmir.1776.
PubMed 21676694
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01145690
- Acronym / sponsor ID
- SOFIE-5YFU / SOFIE-5YFU
- Conditions
- Social Anxiety Disorder
- Keywords
- cognitive behaviour therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder.
In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based CBT | – | –All participants in this cohort received Internet-based CBT for social anxiety disorder in 2005. All participants were Swedish adults with a DSM-IV diagnosis of social anxiety disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample is constituted by all 80 participants who received Internet-based CBT in 2005 within the context of a RCT in Sweden.
Key inclusion criteria (1 listed)
- Must have a primary diagnosis of social phobia
Key exclusion criteria (8 listed)
- Substance abuse during the last 6 months
- Other dominating diagnosis (not phobic personality disorder)
- A history of bipolar disorder or psychosis
- Major depression according to DSM-IV and >20 on madrs-s
- Risk of suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS)
Time frame: 5-year follow-up
5 secondary outcomes
Measures of social anxiety in interaction and performance situations - SIAS & SPS
Time frame: 5-year follow-up
Measure of depressive symptoms - MADRS-S
Time frame: 5-year follow-up
Measure of general anxiety - BAI
Time frame: 5-year follow-up
Measure of quality of life - QOLI
Time frame: 5-year follow-up
Measure of social anxiety disorder diagnosis - SPSQ
Time frame: 5-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
- Derived from this study: PubMed 21676694Hedman E, Furmark T, Carlbring P, Ljotsson B, Ruck C, Lindefors N, Andersson G. A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. J Med Internet Res. 2011 Jun 15;13(2):e39. doi: 10.2196/jmir.1776.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (time frame: 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2010.